NCT07001501

A Clinical Study of the Interactions Between Azvudine Tablets (FNC) and Itraconazole Capsules (ICZ)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Henan Genuine Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Azvudine(FNC)，a nucleoside reverse transcriptase inhibitor, make itself a better candidate to be co-formulated in other anti-HIV therapies, thus to improve patient's compliance. FNC is a broad-spectrum RNA virus inhibitor that inhibits the novel coronavirus RNA-dependent RNA polymerase (RdRp). This is a clinical study to evaluate the Interactions between Azvudine Tablets (FNC) and Itraconazole Capsules (ICZ) in healthy subjects. This is a single-center, randomized, open-label, three-cycles, three-treatment crossover clinical trial. Subjects was administered orally for 10 consecutive days each cycle, and the washout period between each cycle was 14 days. Biological sample collection and safety examination were performed.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Azvudine tablets(FNC) and Itraconazole Capsules (ICZ)	This study consisted of 3 cycles, each cycle was administered orally for 10 consecutive days, and the washout period between each cycle was 14 days. Subjects were administered the drug as follow: FNC 3 mg (1 tablet)+ICZ 200 mg (2 capsules) (taken at the same time), 1 time a day, orally, for 10 consecutive days; FNC: 3 mg (1 tablet) each time, 1 time a day, orally, for 10 consecutive days; ICZ: 200 mg (2 capsules) each time, 1 time a day, orally, for 10 consecutive days.
DRUG	Azvudine tablets(FNC) and Itraconazole Capsules (ICZ)	This study consisted of 3 cycles, each cycle was administered orally for 10 consecutive days, and the washout period between each cycle was 14 days. Subjects were administered the drug as follow: ICZ: 200 mg (2 capsules) each time, 1 time a day, orally, for 10 consecutive days; FNC 3 mg (1 tablet)+ICZ 200 mg (2 capsules) (taken at the same time), 1 time a day, orally, for 10 consecutive days; FNC: 3 mg (1 tablet) each time, 1 time a day, orally, for 10 consecutive days.
DRUG	Azvudine tablets(FNC) and Itraconazole Capsules (ICZ)	This study consisted of 3 cycles, each cycle was administered orally for 10 consecutive days, and the washout period between each cycle was 14 days. Subjects were administered the drug as follow: FNC: 3 mg (1 tablet) each time, 1 time a day, orally, for 10 consecutive days; ICZ: 200 mg (2 capsules) each time, 1 time a day, orally, for 10 consecutive days; FNC 3 mg (1 tablet)+ICZ 200 mg (2 capsules) (taken at the same time), 1 time a day, orally, for 10 consecutive days.

Timeline

• Start date: 2022-02-21
• Primary completion: 2022-04-25
• Completion: 2023-03-13
• First posted: 2025-06-03
• Last updated: 2025-06-03

Locations

1 site across 1 country: China